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FDA 510(k)

SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE

K-Number: K042314 · 2004-11-22

ApplicantBiogen
Decision Date2004-11-22
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Biogen. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K042314. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE?

SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Biogen. The 510(k) number is K042314.

When did SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE receive FDA 510(k) clearance?

SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE received FDA 510(k) clearance on 2004-11-22, under 510(k) number K042314.

Who is the listed applicant for SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE?

The FDA 510(k) record lists Biogen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE?

The FDA product code for SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE is FMF.

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Other records listing Biogen as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K032425INVISIJECT RESUSABLE AUTO-INJECTOR

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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